Shares of ASX-listed biotechnology company Mesoblast Ltd (ASX:MSB) ended 1.28% lower at AU$1.16 apiece on Wednesday, underperforming the ASX 200 index, which closed 1.17% higher today. Although there was no specific reason that can be attributed to today’s fall in Mesoblast share price, it could be because of profit booking following over 5% gains in the stock in the last two trading sessions.
The company on Monday (31 January 2022), released its operational and financial activity report for the second quarter ended 31 December 2021.
In its key financial highlights for the quarter, the company revealed the following details:
- Revenues stood at US$3.5 million including US$2.3 million from TEMCELL® HS Inj.3 royalties on sales for SR-aGvHD in Japan. This was 7% higher compared to the corresponding period last year.
- Cash usage in operating activity reduced by 38% year-on-year to US$19.8 million during the quarter. Almost half of this amount was used for remestemcel-L regulatory and manufacturing activities.
- Refinancing of its senior secured debt facility with a new US$90 million five-year facility completed.
- Cash on hand stood was US$94.8 million at the quarter-end, with up to an additional US$40 million available to be drawn down from current financing facilities subject to certain milestones.
The company also shared operational updates around the potential resubmission of the Biologics License Application (BLA) for the company’s remestemcel-L therapy.
The BLA submission is for the purpose of investigating remestemcel-L in the treatment of children with steroid-refractory acute graft versus host disease (SR-aGVHD). The company said this is a potentially life-threatening complication of an allogeneic bone marrow transplant.
Mesoblast has also held a meeting with the US Food and Drug Administration (FDA)’s Office of Tissues and Advanced Therapies (OTAT) division to address items identified in a complete response letter (CRL) for the compound.
It may be noted that FDA issues a CRL when it seeks more information on a new drug application. Its queries can be about the compounds or the manufacturing facility where the drugs are proposed to be manufactured.
According to the company’s statement, Mesoblast needs to establish the relevance of the compound’s immunomodulatory activity to a set of clinical outcomes to move forward.
The company also stated that a previous study on the drug, published in the Journal of Bone Marrow Transplantation, showed remestemcel-L treatment was associated with a “64% survival in children with biomarker levels predictive for highest mortality [of SR-aGVHD] compared with only 10% survival in controls treated with other available therapies”.
What is SR-aGVHD?
GVHD is defined as a condition when there is severe inflammation in the bloodstream due to the complications of bone marrow transplants. The disease is usually spotted in roughly 50% of the 30,000 patients receiving an allogeneic bone marrow transplant each year, mostly during treatment for blood cancers. Mortality can be 90% in patients suffering from the most severe form of GVHD. Still, no treatments have been approved for treating SR-aGVHD in children less than 12 years of age.
Today, the regenerative medicine company announced appointment of Dr Eric Rose as its Chief Medical Officer (CMO).